V2 TriVerse Femoral Cutting Block

GUDID 09348215128289

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 09348215128289
• NIH Device Record Key: db9edd27-40b4-47b2-a3e1-1c199f3109b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V2 TriVerse Femoral Cutting Block
• Version Model Number: 122-22-4357
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348215128289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222380

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

[09348215128289]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-12
• Device Publish Date: 2025-03-04

On-Brand Devices [V2 TriVerse Femoral Cutting Block]

• 09348215128364: 122-22-4380
• 09348215128357: 122-22-4375
• 09348215128340: 122-22-4372
• 09348215128333: 122-22-4370
• 09348215128326: 122-22-4367
• 09348215128319: 122-22-4365
• 09348215128302: 122-22-4362
• 09348215128296: 122-22-4360
• 09348215128289: 122-22-4357